Laser Link HS

GUDID 00810096330338

Lumenis Be, Inc.

Laser adaptor
Primary Device ID00810096330338
NIH Device Record Keyc1c40fd0-51ef-446c-b231-4a10594c6337
Commercial Distribution StatusIn Commercial Distribution
Brand NameLaser Link HS
Version Model NumberLaser Link HS 532nm
Company DUNS118292380
Company NameLumenis Be, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810096330338 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-10
Device Publish Date2023-04-02

On-Brand Devices [Laser Link HS]

00810096330338Laser Link HS 532nm
00810096330321Laser Link HS 532/577/659nm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.